MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Infants that are born preterm are at risk of developing a severe and life threatening intestinal disease referred to as necrotizing enterocolitis (NEC). This condition is known to be under influence of several factors including the microorganisms that start to colonize the intestine immediately after birth.

We wanted to see whether fecal matter collected from healthy 10-day old piglets, would benefit the pattern of early colonization, and prevent NEC.

Melissa Lorenzo MDPediatric medical residentDr. Lorenzo is currently training at the University of Toronto, however the research was conducted while a medical student at Queens University

MedicalResearch.com: What is the background for this study?

Response: Preterm infants are born before 37 weeks gestation, with late preterm neonates defined as infants born between 34 weeks to 37 weeks gestation. Of all preterm births, over 70% of babies are born in the late preterm period. Late preterm births are common, affecting 12.5% of all births in the United States.

Compared to infants born at term, late preterm neonates are at increased risk for many common complications following birth such as jaundice, low blood sugar, and respiratory distress, prolong hospital stay, admission to the neonatal intensive care unit, and increase readmission rate after hospital discharge. There are many causes for preterm delivery- two important ones are early onset of labour either spontaneous or after premature rupture of membranes, and medically indicated delivery prior to full term gestation due to chronic diseases in mother affecting her health in pregnancy, fetal medical reasons, or placental insufficiency. There is a debate that the risk of neonatal complications is affected by the causes of preterm delivery with immaturity acting as a contributing factor. The relative contribution of immaturity versus the reason for delivery and the resulting neonatal complications is unclear.

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The U.S. Institute of Medicine (IOM) in 2007 published estimates of the economic costs associated with preterm birth. That report is publicly available: https://www.ncbi.nlm.nih.gov/pubmed/20669423. The total societal cost over a lifetime of a single year’s cohort of infants born preterm was estimated as $26 billion in 2005 US dollars. The study in Pediatrics sought to provide more current estimates of one component of those costs: medical care between birth and 12 months and to answer two additional questions:

What costs are specifically incurred by employer-sponsored private health plans?

How much of the overall cost burden of prematurity is attributable to infants born preterm with major birth defects (congenital malformations and chromosome abnormalities)?

Response: Cancer during pregnancy is a rare event. Whether prenatal exposure to a maternal malignancy and its treatment during pregnancy impair fetal development and neonatal health is, however, of great clinical concern. The risks of fatal outcomes such as stillbirth and infant mortality, however, have rarely been successfully explored in pregnancies complicated with cancer, in either clinical or population-based studies.

MedicalResearch.com: What are the main findings?

Response: Maternal cancer diagnosed during pregnancy was associated with increased risk of stillbirth (Incidence Rate Ratio, IRR, 2.5; 95% CI, 1.2 to 5.0), mainly stillbirths assessed as small for gestational age (SGA), and with increased risk of preterm SGA births (relative risk 3.0; 95% CI, 2.1 to 4.4). Maternal cancer diagnosed during pregnancy or the year after pregnancy were associated with increased risks of both neonatal mortality (deaths within 0 to 27 days; IRR, 2.7; 95% CI, 1.3 to 5.6 and IRR, 2.0; 95% CI, 1.2 to 3.2, respectively) and preterm birth (IRR, 5.8; 95% CI, 5.3 to 6.5 and IRR, 1.6; 95% CI, 1.4 to 1.8, respectively). The positive association with preterm birth was due to iatrogenic instead of spontaneous preterm birth. Preterm birth explained 89% of the association of maternal cancer during pregnancy with neonatal mortality.

MedicalResearch.com: What should readers take away from your report?

Response: Maternal cancer diagnosed during pregnancy was associated with increased risks of stillbirths assessed as SGA and preterm SGA live birth, suggesting that cancer and its treatment during pregnancy may impair fetal growth. Maternal cancer diagnosed during or shortly after pregnancy was associated with an increased risk of neonatal mortality, largely attributable to iatrogenic preterm birth. Although stillbirth and neonatal death are rare outcomes, the absolute risks of SGA and preterm birth are not small in pregnancies complicated with cancer. Careful monitoring of fetal growth and cautious decision making on the choices as well as the timing of preterm delivery should therefore be reinforced in these pregnancies.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Response: Sweden is among the high-income countries with the lowest stillbirth and infant mortality rates, and these rates have decreased over time in many populations. Future studies in other populations are warranted to confirm our findings. Our data have also highlighted several cancer types, such as blood cancer, ovarian cancer, and cervical cancer, which entail highly increased risk of SGA or preterm birth and might be worthy of further exploration.

Response: Over the last decades, advances in perinatal care have led to improved survival of extremely preterm infants in most countries. Still, the decision to initiate or withhold active care for infants at the border of viability is challenging. Different attitudes and traditions in perinatal care influence the rates of stillbirths, admissions to intensive care and outcomes. Consequently, there is a continuous need for up-to-date results to guide caregivers and parents in decision making, and to evaluate current medical practices.

Medical Research: What is the background for this study? What are the main findings?

Response: The lungs of preterm infants are very vulnerable and these infants frequently develop chronic lung disease, also called bronchopulmonary dysplasia (BPD). BPD is not only a problem of the lungs, it is also a major cause of early death in these infants and if they survive, their risks of respiratory problems in later life and neurodevelopmental impairment are increased when compared to infants without bronchopulmonary dysplasia. Few drugs are available to prevent or to treat BPD and up to this date, no licensed drug for this indication is on the market, neither in Europe nor the USA. Hence additional preventive strategies are needed to reduce the risk of BPD and inhaled glucocorticoids seemed to have a favorable benefit-risk ratio.

Medical Research: What are the main findings?

Response: A total of 863 preterm infants with a gestational age of less than 28 weeks from 40 study centers in 9 countries (8 European countries and Israel) participated in the Neonatal European Study of Inhaled Steroids (NEUROSIS). The study investigated whether inhaled budesonide, an anti-inflammatory glucocorticoid, would decrease the incidence of bronchopulmonary dysplasia and death in preterm infants. The results show for the first time that inhaled budesonide reduces the incidence of BPD in preterm infants, a finding that is statistically significant. However, in absolute numbers, more infants died during the study period in the budesonide group compared to the placebo group. This difference is not statistically significant and could be caused by chance. Budesonide had a statistically significant positive effect on two more prespecified secondary outcomes: it reduced the rate of infants requiring intubation after completion of study treatment and the frequency of surgery required to close a patent ductus arteriosus, a blood vessel connecting the pulmonary artery to the aorta. The rate of side effects was similar in the budesonide and in the placebo group.

Prof. Poets: Episodes of intermittent hypoxemia (lack of oxygen) and bradycardia (slow heart rate) are common in very preterm infants and often a subject of considerable concern. However, up to now there has been a lack of knowledge as to how often or how long such episodes may occur without increasing an infant’s risk for impaired development or even death.

In this study, we utilized long-term recordings (lasting 8-12 weeks) of oxygen saturation and heart rate obtained as part of the Canadian Oxygen Trial (COT), a large study performed in extremely immature infants and comparing a higher with a lower oxygen saturation target range (85-89 vs. 91-95% oxygen saturation measured by pulse oximetry). For this secondary analysis, we wanted to test the hypotheses that spending a high proportion of time at an oxygen saturation below 80% or a pulse rate <80 beats per minute increases the risk of the following adverse outcomes:

Death after reaching a post-menstrual age of 36 weeks (i.e. 4 weeks before their due date) or disability, determined at 18-22 months corrected age and defined as motor impairment, cognitive or language delay, severe hearing loss, or bilateral blindness;

Prof. Poets: Analyzable recordings and outcome data were available for 1019 infants, of which the least affected 10% spent 0.4%, and the most affected infants 13.5% of the time at an oxygen saturation <80%. We found that the risk to develop all of the adverse outcomes mentioned above increased with the percentage of time spent at an oxygen saturation below 80%, but this was true only for hypoxemic events lasting for at least 1 minute. Episodes with a low heart rate (in the absence of concomitant hypoxemia) were not associated with an increased risk of an adverse outcome. Interestingly, hypoxemic events occurring in infants originally randomized to the higher oxygen group in the original COT study were associated with a stronger increase in the risk of death or disability than such episodes occurring infants randomized to the lower oxygen saturation target range. Continue reading →

Medical Research: What is the background for this study? What are the main findings?

Prof. Breakspear: The first 72 hours following complicated full-term or premature delivery of a newborn represents a critical window in which survival and long term brain development hangs in the balance. During this window of time, there does not currently exist a reliable, non-invasive, real-time measure of neuropathology that provides neurologists and neonatologists prognostic indicators of clinical outcome. We developed a tool that draws on techniques in physics used to characterize naturally occurring phenomena, such as earthquakes and avalanches, to analyze brain activity recordings of preterm infants. Our tool allows early identification of preterm infants at significant risk of developing poor long-term neurodevelopmental outcomes, such as cerebral palsy and learning difficulties at two years of age.

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